ParentingNCT04981730

The Development and Evaluation of a Web-based Childbirth and Parenting Intervention Program

A study testing Web-based intervention in people with Parenting and Self Efficacy, run by Taipei Medical University at 1 site in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Background: The transition to parenthood is stressful for first-time mothers and fathers and links to adverse health outcomes. Despite Internet use's popularity, an effective web-based, individually-tailored intervention to enhance parental self-efficacy and infant health for first-time parents remains lacking. Read more about this study

Who is it for?: Ages 20 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Parenting, Self Efficacy, Psychological Distress
What is being tested?: Web-based intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 600 participants
Where: 1 siteTaiwan
Study dates: 14 Dec 2023to 14 Oct 2025
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 60 years
All sexes
Healthy volunteers accepted
Adult

Inclusion Criteria: for this study are first-time mothers and fathers who are

20 years old and above;
primipara with a singleton pregnancy at second and third-trimester gestation;
able to read and write in Mandarin;
the husband or support partner will be willing to attend the intervention program;
able to access and use the Internet by computer and/or smartphone daily.

Exclusion Criteria: are the first-time mothers and fathers who have

chronic diseases;
obstetric complications;
an abnormal fetal screening;
unable or unwilling to comply with the requirements of the research protocol;
women and their partners did not have time for the web-based intervention program;
participation on any other interventional study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Shu-Yu Kuo contact

+886-2-2736-1661 ext. 6301

sykuo@tmu.edu.tw

Taiwan1 site, 1 recruiting

Taipei Medical University Hospital
Taipei, 110
Shu-Yu Kuo, Phd, +886-2-2736-1661 ext. 6301, sykuo@tmu.edu.tw
Recruiting

Other trials in Taiwan

About this study

Official title: The Development and Evaluation of a Web-based Childbirth and Parenting Intervention Program: A Randomized Controlled Trial

Objectives: This study aims to develop and evaluate the effectiveness of a web-based, individually-tailored childbirth and parenting intervention program on parenting self-efficacy and infant health outcomes. The feasibility and acceptability of a theory-driven intervention will be examined in first-time mothers and fathers.

Methods: A two-arm, single-blind randomized controlled trial will be conducted to investigate the effects of web-based intervention in the first-time mother and father. Participants will be randomly allocated to a web-based intervention or a control condition. A repeated measurement will be performed.

Anticipatory results: The efficacy of a theory-driven web-based, individually tailored intervention program will provide a valuable contribution to perinatal health care for first-time mothers and fathers.

Read the detailed description

The primary outcome of parenting self-efficacy and breastfeeding self-efficacy. The secondary outcomes of anxiety, depression, sleep quality, social support, infant health outcomes will be assessed. Data will be analyzed with the intention-to-treat analysis using linear mixed-effects modeling.

Conditions: Parenting, Self Efficacy, Psychological Distress
Being tested: Web-based intervention
Keywords: parenting, parenthood, web-based intervention, self-efficacy, psychological distress, infant health

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Web-based interventionBehavioural
The web-based intervention participants will follow the website's orientation, the curriculum of modules, and professional feedback to complete the intervention.

Study groups in NCT04981730
Study group	Role	What they receive
Web-based intervention	Experimental	Participants in the intervention will receive both the standardized usual care and guided web-based, individually-tailored childbirth and parenting intervention program, consisting of training sessions plus weekly email, message, or video-conference contact from their assigned nurse specialist. Receives: Behavioral: Web-based intervention
Control	No intervention	Participants in the control group will receive attention from the research nurse and the standardized usual care.

What is being measured

The primary outcome is the main question the study is designed to answer.

Parenting self-efficacy
Parenting self-efficacy will be measured and reported by Parenting Self-Efficacy Scale. The higher the total scores indicate greater perceived parental self-efficacy.
Measured: Baseline
Breastfeeding self-efficacy
Breastfeeding self-efficacy was measured using the Taiwanese version of the Maternal Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) and Breastfeeding self-efficacy Scale-Short Form among fathers (BSES-SFF). Total scores range from 14 to 70, with higher scores representing a higher level of self-efficacy.
Measured: Baseline
Parenting self-efficacy
Parenting self-efficacy will be measured and reported by Parenting Self-Efficacy Scale. The higher the total scores indicate greater perceived parental self-efficacy.
Measured: the third trimester of pregnancy
Breastfeeding self-efficacy
Breastfeeding self-efficacy was measured using the Taiwanese version of the Maternal Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) and Breastfeeding self-efficacy Scale-Short Form among fathers (BSES-SFF). Total scores range from 14 to 70, with higher scores representing a higher level of self-efficacy.
Measured: the third trimester of pregnancy
Parenting self-efficacy
Parenting self-efficacy will be measured and reported by Parenting Self-Efficacy Scale. The higher the total scores indicate greater perceived parental self-efficacy.
Measured: 1-month postpartum
Breastfeeding self-efficacy
Breastfeeding self-efficacy was measured using the Taiwanese version of the Maternal Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) and Breastfeeding self-efficacy Scale-Short Form among fathers (BSES-SFF). Total scores range from 14 to 70, with higher scores representing a higher level of self-efficacy.
Measured: 1-month postpartum
Parenting self-efficacy
Parenting self-efficacy will be measured and reported by Parenting Self-Efficacy Scale. The higher the total scores indicate greater perceived parental self-efficacy.
Measured: 3-month postpartum
Breastfeeding self-efficacy
Breastfeeding self-efficacy was measured using the Taiwanese version of the Maternal Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) and Breastfeeding self-efficacy Scale-Short Form among fathers (BSES-SFF). Total scores range from 14 to 70, with higher scores representing a higher level of self-efficacy.
Measured: 3-month postpartum

Secondary outcomes (9)

Depressive symptoms
Depressive symptoms will be measured using the Taiwanese version of the Edinburgh Postnatal Depression Scale (T-EPDS). Total scores range from 0 to 30, A higher score indicated a higher levels of depression, with a total score of 30.
Measured: Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum
Anxiety symptoms
Anxiety symptoms will be measured using the Taiwanese version of the State-Trait Anxiety Inventory (TSTAI). Total scores range from 20 to 80, with a high score indicating a high level of anxiety.
Measured: Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum
Sleep quality
Sleep quality and disturbance will be measured using the Chinese version Pittsburgh Sleep Quality Index (CPSQI). CPSQI is a self-reported questionnaire and assesses seven sleep quality components from 0 to 3, with a total score ranging from 0 (good sleep) to 21 (very poor sleep).
Measured: Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum
Social support
Social support will be measured using the Chinese version of the multidimensional scale of perceived social support (MSPSS). The higher the score, the higher the degree of support; total score ranging from 12 to 84.
Measured: Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum
Infant feeding methods
Infant feeding methods will be measured using a self-report questionnaire. The feeding methods, including initiated breastfeeding within 24h after birth, and type of breastfeeding.
Measured: Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum
Infant sleep quality
The infant sleep quality will be measured using the Taiwanese version of the Brief Infant Sleep Questionnaire (BISQ). The BISQ will be used to assess sleep duration, duration of sleep by circadian rhythm, and night-time awakenings.
Measured: 1-month postpartum and 3-month postpartum
Infant development
Infant development will be measured using the Taipei City Developmental Checklist for the assessment of developmental delay.
Measured: 3-month postpartum
Feasibility measured using a structured questionnaire
The feasibility of this trial will be measured using a structured questionnaire.
Measured: immediately after intervention
Satisfaction measured using a structured questionnaire
Participants' satisfaction will be measured using a structured questionnaire.
Measured: immediately after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Dec 202314 Oct 2025

First posted29 Jul 2021
Study start14 Dec 2023
Primary completion14 Oct 2025 (estimated)
Study completion14 Oct 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ParentingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 600 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04981730
Sponsor's protocol ID: N202103092
Status last verified: Jan 2025
First submitted: 8 Jul 2021
Last updated: 28 Jan 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

Shu-Yu Kuo

+886-2-2736-1661 ext. 6301

sykuo@tmu.edu.tw

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Chicago Parent Program for Foster and Kinship Caregivers
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Online Feeding Education for Fathers of Children With Feeding Problems
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CHOICES3: Sickle Cell Disease Parenting CHOICES
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All Parenting trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Development and Evaluation of a Web-based Childbirth and Parenting Intervention Program: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT04981730
Acronym / sponsor ID: N202103092
Conditions: Parenting, Self Efficacy, Psychological Distress
Keywords: parenting, parenthood, web-based intervention, self-efficacy, psychological distress, infant health
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 600 participants (estimated)
Lead sponsor: Taipei Medical UniversityUniversity, hospital or other
Study start: 14 Dec 2023 (actual)
Primary completion: 14 Oct 2025 (estimated)
Study completion: 14 Oct 2025 (estimated)
First posted: 29 Jul 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Web-based intervention	Experimental	Behavioral: Web-based interventionParticipants in the intervention will receive both the standardized usual care and guided web-based, individually-tailored childbirth and parenting intervention program, consisting of training sessions plus weekly email, message, or video-conference contact from their assigned nurse specialist.
Control	No intervention	–Participants in the control group will receive attention from the research nurse and the standardized usual care.

Who may qualify

Ages: 20 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Web-based interventionThe web-based intervention participants will follow the website's orientation, the curriculum of modules, and professional feedback to complete the intervention.	Behavioural	Web-based intervention

Primary outcome

Parenting self-efficacy
Time frame: Baseline
Parenting self-efficacy will be measured and reported by Parenting Self-Efficacy Scale. The higher the total scores indicate greater perceived parental self-efficacy.
Breastfeeding self-efficacy
Time frame: Baseline
Breastfeeding self-efficacy was measured using the Taiwanese version of the Maternal Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) and Breastfeeding self-efficacy Scale-Short Form among fathers (BSES-SFF). Total scores range from 14 to 70, with higher scores representing a higher level of self-efficacy.
Parenting self-efficacy
Time frame: the third trimester of pregnancy
Parenting self-efficacy will be measured and reported by Parenting Self-Efficacy Scale. The higher the total scores indicate greater perceived parental self-efficacy.
Breastfeeding self-efficacy
Time frame: the third trimester of pregnancy
Breastfeeding self-efficacy was measured using the Taiwanese version of the Maternal Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) and Breastfeeding self-efficacy Scale-Short Form among fathers (BSES-SFF). Total scores range from 14 to 70, with higher scores representing a higher level of self-efficacy.
Parenting self-efficacy
Time frame: 1-month postpartum
Parenting self-efficacy will be measured and reported by Parenting Self-Efficacy Scale. The higher the total scores indicate greater perceived parental self-efficacy.
Breastfeeding self-efficacy
Time frame: 1-month postpartum
Breastfeeding self-efficacy was measured using the Taiwanese version of the Maternal Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) and Breastfeeding self-efficacy Scale-Short Form among fathers (BSES-SFF). Total scores range from 14 to 70, with higher scores representing a higher level of self-efficacy.
Parenting self-efficacy
Time frame: 3-month postpartum
Parenting self-efficacy will be measured and reported by Parenting Self-Efficacy Scale. The higher the total scores indicate greater perceived parental self-efficacy.
Breastfeeding self-efficacy
Time frame: 3-month postpartum
Breastfeeding self-efficacy was measured using the Taiwanese version of the Maternal Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) and Breastfeeding self-efficacy Scale-Short Form among fathers (BSES-SFF). Total scores range from 14 to 70, with higher scores representing a higher level of self-efficacy.

9 secondary outcomes

Depressive symptoms
Time frame: Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum
Anxiety symptoms
Time frame: Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum
Sleep quality
Time frame: Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum
Social support
Time frame: Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum
Infant feeding methods
Time frame: Baseline, the third trimester of pregnancy,1-month postpartum and 3-month postpartum
Infant sleep quality
Time frame: 1-month postpartum and 3-month postpartum
Infant development
Time frame: 3-month postpartum
Feasibility measured using a structured questionnaire
Time frame: immediately after intervention
Satisfaction measured using a structured questionnaire
Time frame: immediately after intervention

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.

Related trials for Parenting

Active, not recruiting
Chicago Parent Program for Foster and Kinship Caregivers
Behavior Problem, Parenting
Active, not recruiting
Tailoring CPP for the Foster Care Setting
Behavior Problem
Recruiting
Online Feeding Education for Fathers of Children With Feeding Problems
Feeding Problems, Parent Training
Recruiting
Fathers and Babies (FAB) Research Study
Perinatal Mental Health, Fathers
Active, not recruiting
CHOICES3: Sickle Cell Disease Parenting CHOICES
Sickle Cell Disease, Sickle Cell Trait

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Shu-Yu Kuo contact

+886-2-2736-1661 ext. 6301

sykuo@tmu.edu.tw

Shu-Yu Kuo principal investigator

Taipei Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Web-based intervention in people with Parenting and Self Efficacy, run by Taipei Medical University at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shu-Yu Kuo (+886-2-2736-1661 ext. 6301, sykuo@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Parenting self-efficacy (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04981730.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.